(111 days)
The HumidAire 2i is indicated for the humidification of the air delivered from a ResMed compatible CPAP therapy device.
The HumidAire 2i is intended for single patient re-use in the home environment and multi-patient re-use in a hospital / institutional environment.
The HumidAire 2i is for use only as recommended by a physician.
ResMed's HumidAire 2i™ is a humidify the air delivered to the airway during continuous positive airway pressure (CPAP), automatic positive airway pressure (APAP) and bilevel therapy.
The HumidAire 21™ is designed to form a single heated humidification unit when attached to a CPAP, APAP or bilevel device.
The HumidAire 21™ is intended for single patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment.
The ResMed HumidAire 2i is a respiratory gas humidifier. The provided documentation does not detail a clinical study with acceptance criteria and a test set for device performance in the way typically associated with AI/ML devices. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through adherence to established standards and engineering design verification.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it's not applicable for this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states, "Design and Verification activities were performed on the HumidAire 2i™ as a result of the risk analysis and product requirements. All tests confirmed the product met the predetermined acceptance criteria." However, the specific acceptance criteria and the quantitative results of these tests are not provided in the given text.
The "device performance" is implicitly demonstrated through its substantial equivalence to predicate devices and compliance with relevant FDA guidance documents and standards related to respiratory gas humidifiers and reprocessing of medical devices.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable in the context of the provided documentation. The submission focuses on engineering design verification and demonstrating substantial equivalence to predicate devices, rather than a clinical study involving a "test set" of patient data for performance evaluation in the way an AI/ML device would.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable. The ground truth in this context would be related to the device's functional specifications and safety, established through engineering and regulatory standards rather than expert clinical consensus on a test set.
4. Adjudication Method
This information is not applicable. There's no clinical "test set" requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. The HumidAire 2i is a medical device (humidifier), not an AI-assisted diagnostic or therapeutic tool that would typically involve an MRMC study.
6. Standalone Performance Study
This information is not applicable in the context of an "algorithm only without human-in-the-loop performance." The device itself has standalone functionality as a humidifier when attached to a CPAP device. Its performance is assessed through engineering testing and compliance with standards, not an AI-specific standalone performance study.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Engineering specifications and design requirements: These define how the humidifier should function (e.g., humidification output, temperature control, safety features).
- Compliance with applicable standards and requirements: As listed in the document (e.g., FDA Draft Reviewer Guidance for Ventilators, FDA Heated Humidifier Review Guide, and guidance on reprocessing reusable medical devices).
- Substantial equivalence to predicate devices: The predicate devices (AutoSet Spirit™ with H2i and VPAP ADAPT™ with H2i) have established safety and effectiveness.
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" as this is not an AI/ML device.
Summary of Device-Specific Information from the Text:
- Intended Use: Humidification of air delivered from a ResMed compatible CPAP therapy device. Intended for single-patient re-use in home environment and multi-patient re-use in hospital/institutional environment.
- Device Description: Forms a single heated humidification unit when attached to a CPAP, APAP, or bilevel device.
- Substantial Equivalence: Demonstrated through similar intended use (with modification for multi-patient re-use), same operating principle, same technologies, and same manufacturing process as predicate devices.
- Compliance: The device complies with applicable standards and FDA guidance documents related to ventilators, premarket notification submissions, reprocessing of single-use devices, labeling reusable medical devices, and heated humidifiers.
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RESMED
LOR079)
1
HumidAire 2i Traditional 510(k) Premarket Notification
510(k) Summary -- HumidAire 2i™
[As required by 21 CFR 807.92(c)]
| Date Prepared | 14th March 2008 | JUL - 9 2008 |
|---|---|---|
| Official Contact | Dr Lionel KingV.P., Global Quality Assurance & Regulatory AffairsResMed Ltd1 Elizabeth Macarthur DriveBella Vista, NSW 2153AustraliaTel: +61 (2) 8884 1000Fax: +61 (2) 8884 2021 | |
| Classification Reference | 21 CFR 868.5450 (Class II device) | |
| Product Code | 73 BTT | |
| Common/Usual Name | Humidifier, respiratory gas, (direct patient interface) | |
| Proprietary Name | HumidAire 2i™ | |
| Predicate Device(s) | AutoSet Spirit™ with H2i (K013843) - PrimaryVPAP ADAPT™ with H2i (K051364) | |
| Reason for submission | New Device |
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Intended Use
The HumidAire 2i is indicated for the humidification of the air delivered from a ResMed compatible CPAP therapy device.
The HumidAire 2i is intended for single patient re-use in the home environment and multi-patient re-use in a hospital / institutional environment.
The HumidAire 2i is for use only as recommended by a physician.
Device Description
ResMed's HumidAire 2i™ is a humidify the air delivered to the airway during continuous positive airway pressure (CPAP), automatic positive airway pressure (APAP) and bilevel therapy.
The HumidAire 21™ is designed to form a single heated humidification unit when attached to a CPAP, APAP or bilevel device.
The HumidAire 21™ is intended for single patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment.
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate device.
- Similar intended use (modified only to include multiple patient re-use) ો
- /A Same operating principle
- 演 Same technologies
- ﺧﺮ Same manufacturing process
Design and Verification activities were performed on the HumidAire 2i™ as a result of the risk analysis and product requirements. All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that the new device is Substantially Equivalent to the predicate device. The disinfection of the HumidAire 2i for re-use in a hospital/sleep lab environment has not altered the safety and effectiveness when used primarily in the management of patients with Obstructive Sleep Apnea (OSA).
The HumidAire 2i complies with the applicable standards and requirements referenced in the FDA quidance documents:
- ﺎﺯ FDA Draft Reviewer Guidance for Ventilators (July 1995)
- ;A Reviewer Guidance for Premarket Notification Submissions, November 1993, ARDB, CDRH, FDA
- 公 Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme: Draft
- FDA Reviewer Guidance: "Labeling reusable medical devices for reprocessing in health care facilities" 产 (Office of device evaluation, April 1996)
- FDA Heated Humidifier Review Guide 从
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 2008
ResMed Limited C/O Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K080797
Trade/Device Name: HumidAire 2iTM Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: June 5, 2008 Received: June 27, 2008
Dear Mr. D'Cruz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Mr. D'Cruz
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
V.K. Ammels-Tend, m.D. /for
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known):
Device Name:
HumidAire 2i™
Indication for Use
The HumidAire 21 is indicated for the humidification of the air delivered from a ResMed compatible CPAP therapy device.
The HumidAire 2 is intended for single patient re-use in the home environment and multi-patient re-use in a hospital / institutional environment.
The HumidAire 2i is for use only as recommended by a physician.
Prescription Use _ X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
hml
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
14* March, 2008
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).